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Duagen (dutasteride) Soft Gelatin Capsules

Duagen (dutasteride) is for use by men only.

Read this information carefully before you start taking Duagen (dutasteride) . Read the information you get with Duagen (dutasteride) each time you refill your prescription. There may be new information. This information does not take the place of talking with your doctor.

What is Duagen (dutasteride) ?

Duagen (dutasteride) is a medication to treat men who have symptoms of benign prostatic hyperplasia.

Duagen (dutasteride) is not a treatment for prostate cancer. See the end of this leaflet for information about how Duagen (dutasteride) works.

Who should NOT take Duagen (dutasteride) ?

• Women and children should not take Duagen (dutasteride) . A woman who is pregnant or capable of becoming pregnant should not handle Duagen (dutasteride) capsules. See "What are the special warnings for women about Duagen (dutasteride) ?"

• Do not take Duagen (dutasteride) if you have had an allergic reaction to Duagen (dutasteride) or any of its ingredients.

• Tell your doctor if you have liver problems. Duagen (dutasteride) may not be right for you.

What are the special warnings for women about Duagen (dutasteride) ?

• Women should never take Duagen (dutasteride) ,

• Women who are pregnant or may become pregnant should not handle Duagen (dutasteride) Capsules. If a woman who is pregnant with a male baby gets enough Duagen (dutasteride) into her body after

swallowing it or through her skin after handling it, the male baby may be born with abnormal sex organs.

What are the special precautions about Duagen (dutasteride) ?

• Men treated with Duagen (dutasteride) should not donate blood until at least 6 months after their final dose to prevent giving Duagen (dutasteride) to a pregnant female through a blood transfusion.

How should I take Duagen (dutasteride) ?

• Take 1 Duagen (dutasteride) capsule once a day.

• Swallow the capsule whole.

• You can take Duagen (dutasteride) with or without food.

• If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

• You may find it helpful to take Duagen (dutasteride) at the same time every day to help you remember to take your dose.

What are the possible side effects of Duagen (dutasteride) ?

The most common side effects of Duagen (dutasteride) are impotence (trouble getting or keeping an erection), a decrease in libido (sex drive), and enlarged breasts. Also, some men may notice a decrease in the amount of semen they release during sex,

Talk with your doctor if you have questions about these and other side effects that you think may be related to taking Duagen (dutasteride) .

How should I store Duagen (dutasteride) ?

Duagen (dutasteride) is a soft gelatin capsule that may become soft and leak or may stick to other capsules if kept at high temperatures. Store Duagen (dutasteride) capsules at room temperature of 77°F (25°C) or lower.

If your capsules are cracked or leaking, don't use them, and contact your pharmacist.

General information about Duagen (dutasteride) .

• Do not use Duagen (dutasteride) for a condition for which it was not prescribed.

• Do not share your Duagen (dutasteride) .

• Ask your doctor about how often you should return for a visit to check your BPH.

• A blood test called PSA (prostate-specific antigen) is sometimes used to detect prostate cancer. Duagen (dutasteride) will reduce the amount of PSA measured in your blood. Your doctor is aware of this effect and can still use PSA to detect prostate cancer in you.

• If you have questions about Duagen (dutasteride) , ask your doctor or pharmacist. They can show you detailed information about Duagen (dutasteride) that was written for healthcare professionals.

How does Duagen (dutasteride) work?

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT).

Duagen (dutasteride) lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men. Just as your prostate became large over a long period of time, reducing the size of your prostate and improving your symptoms will take time. While some men have fewer problems and symptoms after 3 months of treatment with Duagen (dutasteride) , a treatment period of at least 6 months is usually necessary to see if Duagen (dutasteride) will work for you.

Manufactured by: RP Scherer Beinheim, France for



Research Triangle Park, NC 27709

© 2001, GlaxoSmithKline

All rights reserved.

Updated Sep 05, 2003

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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